Press Release- PrimewayMED partners with Siemens Healthineers to Distribute CLINITEST Self-Test
PrimewayMed partners with Siemens Healthineers
to Distribute CLINITEST® Rapid COVID-19 Antigen Self-Test
Plymouth NH (March 17, 2022) – PrimwayMed, (PM) announced it has teamed up with New York -based Siemens Healthcare Diagnostics, Inc. (Siemens), to distribute the CLINITEST® Rapid COVID-19 Antigen Self-Test. CLINITEST® is a simple-to-use, rapid antigen self-test that does not require a prescription. The CLINITEST® COVID-19 Antigen Self-Test is available for purchase through PM’s corporate website at www.primewaymed.net
On December 29th, 2021, Siemens Healthineers was granted an emergency use authorization (EUA) by the U.S. Food and Drug Administration that will significantly increase the availability of a rapid, self-test to public authorities and private companies.
Together, the combined resources of Siemens and PrimewayMed will dramatically increase the availability of COVID-19 home tests to consumers through a proven and integrated distribution process. Utilizing an innovative market penetration strategy, PM has partnered with an international alliance of seasoned professionals in the medical, pharmaceutical, marketing, and entrepreneurial fields bonded by the mission to provide innovative, effective, and pragmatic solutions in the global battle against the COVID-19 pandemic.
The CLINITEST® Rapid COVID-19 Antigen Self-Test has not been FDA cleared or approved but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of IVDs for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner. For links to Instructions for Use, Fact Sheet for Healthcare Providers, Consumer Package Insert, FDA EUA letter, please visit www.primewaymed.net